Removable biocompatible substrate filter for a reaming and collection device

ABSTRACT

The present invention provides for a removable second stage biocompatible substrate filter that includes biocompatible implant material configured to trap second stage operative particulate matter that may include at least one of bone fragments, plasma, stem cells, cellular matter, and growth factors captured from irrigation fluid. The second stage biocompatible substrate filter may be configured to combine with bone fragments captured from irrigation fluid by a first stage filter and may be configured to be operable with a reaming and collection device.

CROSS REFERENCE TO RELATED APPLICATION

The present application Ser. No. 15/390,796 is a continuation of U.S.patent application Ser. No. 14/305,049 titled Apparatus for HarvestingImproved Bone Graft Material Utilizing an Implantable BiodegradableFilter, filed on Jun. 6, 2014, which, in turn, is a continuation of U.S.patent application Ser. No. 13/091,123 titled Apparatus, System, andMethod for Harvesting Improved Bone Graft Material withReamer-Irrigator-Aspirator (RIA) Device filed on Apr. 21, 2011, which,in turn, claimed priority to U.S. Provisional Patent Application Ser.No. 61/326,234, filed on Apr. 21, 2010, titled Apparatus, System, andMethod for Harvesting Improved Bone Graft Material withReamer-Irrigator-Aspirator (RIA) Device, the entire contents of each ofwhich are hereby incorporated into this application by reference toprovide continuity of disclosure.

FIELD OF THE INVENTION

The present invention is in the technical field of medical devices. Moreparticularly, the present invention is in the technical field ofharvesting bone graft materials using a reamer device.

BACKGROUND OF THE INVENTION

Currently, materials in the output stream from a reaming device, such asthe Reamer-Irrigator-Aspirator provided by Synthes, are not fully andefficiently collected. While there have been some attempts to collectlarge scale material, other materials such as plasma, and other cellularelements are not currently collected and are discarded. Further, theapproach used even to collect the large scale materials, essentiallybone fragments, is not efficient for medical personnel to use in theoperating room.

SUMMARY OF THE INVENTION

The present invention provides for a removable second stagebiocompatible substrate filter that includes biocompatible implantmaterial configured to trap second stage operative particulate matterthat may include at least one of bone fragments, plasma, stem cells,cellular matter, and growth factors captured from irrigation fluid. Thesecond stage biocompatible substrate filter may be configured to combinewith bone fragments captured from irrigation fluid by a first stagefilter, defining a combined product. Furthermore, the second stagefilter may be configured to be operable with a reaming and collectiondevice.

The removable second stage biocompatible substrate filter may have asubstrate that is a porous and hydrophilic membrane that may beconfigured as an implantable product for implantation within humans. Inthis embodiment, the first stage operative particulate matter and thebone fragments may conform to a size and geometric shape consistent withan undulated surface of the second stage filter.

In some embodiments the second stage may be a centrifuge and thecombined product may be configured to unroll into sheets.

In some embodiments the bone fragments from the first stage may be afirst size and the second stage operative particulate matter may be asecond size. Similarly, the second stage biocompatible substrate filtermay comprise a biocompatible implant material configured to retainsecond stage operative particulate matter. The second stagebiocompatible substrate filter may be configured to combine with firststage operative particulate matter captured from irrigation fluid by afirst stage filter. The first stage operative particulate matter mayinclude material of a first size and the second stage operativeparticulate matter may include material of a second size.

The removable second stage biocompatible substrate filter may beconfigured to be operable with a reaming and collection device whereinthe second stage operative particulate matter retained may be one ofbone fragments, plasma, stem cells, cellular matter, and growth factorscaptured from irrigation fluid and the first stage operative particulatematter may include bone fragments. Furthermore, the first stageoperative particulate matter may include at least one of bone fragments,plasma, stem cells, cellular matter, and growth factors captured fromirrigation fluid.

In one embodiment the removable second stage biocompatible substratefilter may include biocompatible implant material configured to retainsecond stage operative particulate matter wherein the second stagebiocompatible substrate filter may be configured to combine withoperative particulate matter captured from irrigation fluid by a firststage filter. The first stage retained material and the second stageretained material may be obtained from a reaming device utilizing anirrigation fluid supply and a suction source. An output of the reamingdevice may be connected to an input of a first stage filter container.In this embodiment, a flow of materials suspended in the irrigationfluid may pass through a first connecting tube and the flow of materialssuspended in the irrigation fluid may be filtered by the first stagefilter. The first stage retained material may be separated from the flowof materials suspended in the irrigation fluid by a filter possessing afirst particulate size selectivity. The first stage filter may furtherprovide a first stage output flow of materials suspended in irrigationfluid. The first stage filter may allow for the collection of a firstsized particulate matter of at least one or more of irrigation fluid,plasma, stem cells, growth factors, and cellular matter. Furthermore,the first stage output flow of materials may be suspended in theirrigation fluid and passed through a first stage output. In thisembodiment the input of a second stage filter container may be connectedby a second connecting tube to the output of the first stage filtercontainer. Therefore, the first stage output flow of materials suspendedin the irrigation fluid may be filtered by the second stage filter. Inthis embodiment the second stage filter may retain a second sizedparticulate matter different than the first stage filter that includes aportion of at least one or more of plasma, stem cells, growth factors,and cellular matter, and may allow for the passing of a portion of theirrigation fluid as output flow. Additionally, the second stage filtercontainer may include an evacuation port to permit the flow of materialssuspended in the irrigation fluid to be evacuated from the second stagefilter container in a continuous process. The continuous process mayinclude the first stage filter container receiving output from thereaming device and output from the second stage filter simultaneously.Therefore, the biocompatible substrate may be configured to receive atleast a portion of the first stage retained material in combination withat least a portion of the second stage retained material to create acombined graft product.

In this embodiment, the substrate may be a porous and hydrophilicmembrane configured as an implantable product for implantation withinhumans. The first stage retained material and the second stage retainedmaterial may conform to a size and geometric shape consistent with anundulated surface of the second stage filter. In some embodiments thesecond stage may be a centrifuge and the combined product may beconfigured to unroll into sheets. Furthermore, the first stage may be agrate and the second stage may be a centrifuge or vice versa. As statedabove, the substrate may be a porous and hydrophilic membrane of a sizeand geometric shape consistent with an undulated surface of the secondstage filter and configured as an implantable product to envelop a humanbone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a diagram of the prior art RIA device.

FIG. 1B is a diagram of the prior art RIA device tubing interface.

FIG. 2 shows the bi-lumen tube conned to a tube port in a RIA or otherdevice.

FIG. 3 shows the improved stage 1 filter with the water irrigation hosebypassing the filter (not integrated).

FIG. 4 shows the Stage 1 filter with an integrated pass throughirrigation source hose for use with the bi-lumen tubing.

FIG. 5 shows the stage 1 filter with the lid open, and stage 1 materialinside.

FIG. 6 shows the removed filter plate from the stage 1 filter with thestage 1 material being collected from the filter plate into a canisterfor later use.

FIG. 7 shows the stage 1 filter connected to a stage 2 collectorcentrifuge, with a collagen sponge or filter cylinder inside in oneembodiment of the invention.

FIG. 8 shows the collagen filter removed from the centrifuge aftercollection, then cut into a flat “pad” of stage 2 material on thecollagen filter or sponge in one embodiment.

FIG. 9 shows the collagen or other filter material removed from thecentrifuge, cut and laid flat as a stage 2 pad.

FIG. 10 shows an alternative stage 2 collector using a filtrationsystem, containing a collagen or other materials filter plate or sponge.

FIG. 11 shows the collagen filter being removed from the stage 2 filter,for use of the retained stage 2 materials.

FIG. 12 shows stage 1 material in one embodiment being added to thestage 2 materials on a collagen filter, pad, or sponge and use as partof a bone graft in a patient. In this case the collagen filter, orsponge would be placed inside the patient along with the stage 1 andstage 2 materials, which may be modified in proportions. The filter, inone embodiment, would dissolve at a later time.

FIG. 13 shows an alternative embodiment of stage 1 materials being addedto the stage 2 materials on a collagen filter, pad, or sponge and use aspart of a bone graft in a patient.

Note that the specific examples provided are not intended to be limitingbut are specific embodiments of the invention. Various alternativematerials and processes may be used as known in the art.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1A, the depiction of the RIA which stands for ReamerIrrigator Aspirator. Depicted is a power source 101, a drill of anyvariety used within the operating room. The RIA device 102 which isdesigned as a medullary bone graft harvesting device. The bone graftmaterial would be harvested from the medullary canal of a native humanfemur 103 using the RIA device 102. A guide wire 104 is inserted intothe medullary canal providing a guide for the RIA device 102 to remainwithin the medullary canal. The reamer head 105 is designed to cut thebone that is currently being harvested by the device. Through Port 106,the entry portal, saline is pumped into the device exiting out of Port107. Suction is applied to the device through Port 109, providing anavenue for fluid as well as bone graft material to exit the medullarycanal via Port 108. It is then tunneled through Port 109 to a collectiondevice or to the waste suction canister within the operating room. FIG.1B is a depiction of the current device in larger scale at the regionwhere the suction as well as irrigation ports meet with the RIA device102. The RIA device 102 with Port 106, is the port allowing for salineto float within the device and Port 109 being the port providing suctionand an avenue for the evacuation of material from the medullary canal.

FIG. 2 is a depiction of the improved tubing system in one embodiment ofthis current invention. Depicted is the RIA device 102 with modifiedcoupling Zones 201 as well as 202. 201 would be the coupling point forsaline inflow into the RIA device 102; whereas, Port 202 would providefor efflux and evacuation of fluid as well as bone graft material thatis applied via suction. The suction source would be obtained through asource available within the operating room. The tubing is coupled 203 toprovide for less entanglement and more streamlined use within theoperating room. These tubes would branch allowing forfiltration/separation canisters, to be described later. Tube 204 wouldprovide an inflow source for saline whereas Tube 205 would providesuction as well as an egress pathway for bone graft as well as saline orother fluids.

FIG. 3 depicts an embodiment of a modified Stage 1 filter for thecollection of materials from the harvesting site. Saline and bone graftmaterial would flow into the device via Tube 205. The device container,301, would contain a hinged lid 302. Within the container 301, would bea Removable Porous Filter, 303, that is porous in nature to capturelarge bone graft material but provide for the flow through of saline,blood products, plasma, cells, and growth factors, and other particulatematter of a specific geometrically limited size. The material would bedrawn through the filter via suction applied through Tube 304. Alsodepicted in FIG. 3 would be Tubing 204 that would allow for saline toflow to the RIA device 102 and provide irrigation to facilitate theevacuation of bone graft material.

FIG. 4 is an alternative embodiment of the Stage 1 filter. Tube 401would be contained within the Filter Device container, 301, once againavoiding significant entanglement and providing for more efficient usewithin the operating room. The remaining portion of the device wouldfunction very similar as the device in FIG. 3. A hinged lid, 302,providing access to Porous Filter 303, would catch material entering viaTube 205 once again allowing for saline, blood products, plasma, cells,growth factors and other particulate matter of a specific geometricallylimited size to pass through and be drawn out via Port 304.

FIG. 5 shows one depiction of the initial stage filter with additionaldetails noted. Through Tube 205 saline as well as graft materialevacuated from the medullary canal would enter Stage 1 container 301.The lid now hinged open, depicted at 302, allows for access to PorousFilter 303 containing Bone Graft Material 501. The remaining portion ofthe fluid, containing blood products, plasma, cells, growth factors andother particulate matter of a specific geometrically limited size wouldbe evacuated via suction, through Tube 304.

FIG. 6 depicts the removal of the material off of Porous Filter 303.Bone Graft Material 501 would then be removed via Spatula Device 601into Container 602. These Devices, 601 as well as 602, would be sterileand used within the operative field. The Collection Container 602provides for a sterile container to contain the Bone Graft Material 501for later re-implantation at the desired clinical site.

FIG. 7 represents one embodiment of the second stage filtration systemwhich would be designed to remove excess water yet retain additionalgraft material including but not limited to blood products, plasma,cellular bone marrow/stem cell elements, as well as growth factors andother particulate matter of a specific geometrically limited size.Depicted in FIG. 7 is the Porous Filter 303 contained within theFiltration container 301 covered by Lid 302. Initial material harvestedfrom the RIA device 102 would enter the container via Tube 205. Largebone graft material would be trapped by Porous Filter 303 allowing forthe pass through/flow through of the remaining material through Tube304. This material once again would represent blood products, plasma,and cellular elements including stem cells as well as growth factors andother particulate matter of a specific geometrically limited size. Thismaterial would then enter Centrifugal Filtration Device 701. This devicewould contain a porous filtration capturing membrane 801. It will becovered and contained within the centrifugal filtration device via Lid703. The porous filtration capturing membrane 801 would be porous in itsdesign to allow for capturing of blood products, plasma, cellularelements/stem cells, as well as growth factors and other particulatematter of a specific geometrically limited size, yet provide for theseparation of fluid. This separation would then allow for aconcentration of the graft elements and further to extract fluid fromthe system via centrifugation. The fluid may exit via Tubing 702connected to an evacuation port in the various embodiments of the secondstage filter as illustrated, for example, in FIG. 7.

FIG. 8 is a detailed depiction of the porous filtration capturingmembrane within the Filtration Device 701. The cylindrical porousfiltration capturing membrane 801 would be removed from CentrifugalFiltration Device 701 and cut to provide for a rectangular surface andfunction as a graft impregnated membrane for re-implantation within thepatient.

FIG. 9, once again, provides for a drawing of this process starting withthe Centrifugal Filtration Device 701 that is sealed via Lid 703.Material filtered through the first stage filtration system enters viaTube 304. After a centrifugal filtration process takes place, within701, the material is trapped within the porous filtration capturingmembrane 801 which is porous in nature to provide for the capture ofblood products, plasma, cellular elements including stem cells, as wellas growth factors and other particulate matter of a specificgeometrically limited size, but allow for the pass through of fluid thatwould exit via Tubing 702 connected to an evacuation port in the variousembodiments of the second stage filter as illustrated, for example, inFIG. 9. The porous filtration capturing membrane 801 could then be cutto size and later implanted within the patient.

FIG. 10 represents an alternative embodiment of the second stage filter.This filter would be designed for a more passive filtration processfacilitated by vacuum negative pressure. Filtration Canister 1002 wouldcontain a Hinged Lid 1003. Material exiting the first stage filter wouldenter the device via Tube 304. The undulating surface depicted as 1005would be a filtration surface undulated for increasing surface area. Itwould reside on top of a porous yet Hydrophilic Membrane 1004 that wouldfacilitate the extraction of fluid. The retention of blood products,plasma, cellular elements including stem cells, growth factors and otherparticulate matter of a specific geometrically limited size, would takeplace on the second stage (or any subsequent stage) filtration surface1005. Excess fluid would then be evacuated via Tube 1001 connected to anevacuation port in the various embodiments of the second stage filter asillustrated, for example, in FIG. 10.

In FIG. 11 a more detailed depiction of the second stage filter andhydrophilic membrane is depicted. The undulating Second Stage Filter1005 would initially lie on top of porous Hydrophilic Membrane 1004. TheFiltration Surface 1005 would then be peeled away fromhydrophilic/porous Surface 1004 after it has been exposed to the secondstage graft/fluid material. This surface would then be available forimplantation within the desired clinical setting.

FIG. 12 represents the final combination of material from the first aswell as second stage of filtration, or any combination of a plurality offiltration stages. Material from the first stage of filtration, depictedas 501, and being contained within Sterile Container 602, would then beplaced on top of Undulating Porous Sponge 1005. This would become acombination graft of large fragments of bone graft material from stage 1combined with desired blood products, plasma, cellular elements/stemcells, growth factors and other particulate matter of a specificgeometrically limited size. This combined graft can then be used in thedesired clinical location. The location being depicted in FIG. 12 as1201, a tibial bone graft site, although other site may be desired.

An alternative embodiment of the combined graft would be depicted inFIG. 13 that would provide for a combination of material from the firststage filtration as well as material captured via centrifugal filtrationdevice and contained within the porous filtration capturing membrane801. Material 501 from the first stage of Filtration would be removedfrom Container 602. It would then be placed on the cut porous filtrationcapturing membrane 801, which would contain blood products, plasma,cellular elements including stem cells as well as growth factors andother particulate matter of a specific geometrically limited size. Thiswould then be made available for implantation within a desired clinicalbone graft site depicted as a tibial site 1301 in FIG. 13, althoughother site may be desired.

It is therefore submitted that the instant invention has been shown anddescribed in what is considered to be the most practical and preferredembodiments. It is recognized, however, that departures may be madewithin the scope of the invention and that obvious modifications willoccur to a person skilled in the art. With respect to the abovedescription then, it is to be realized that the optimum dimensionalrelationships for the parts of the invention, to include variations insize, materials, shape, form, function and manner of operation, assemblyand use, are deemed readily apparent and obvious to one skilled in theart, and all equivalent relationships to those illustrated in thedrawings and described in the specification are intended to beencompassed by the present invention.

Therefore, the foregoing is considered as illustrative only of theprinciples of the invention. Further, since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

That which is claimed is:
 1. A removable second stage biocompatiblesubstrate filter comprising: biocompatible implant material configuredto trap second stage operative particulate matter; wherein the secondstage operative particulate matter includes at least one of bonefragments, plasma, stem cells, cellular matter, and growth factorscaptured from irrigation fluid; wherein the removable second stagebiocompatible substrate filter is configured to combine with bonefragments captured from irrigation fluid by a first stage filter,defining a combined product; wherein the removable second stagebiocompatible substrate filter is configured to be operable with areaming and collection device; and wherein the second stagebiocompatible substrate filter is configured to be removable from afilter device container.
 2. The removable second stage biocompatiblesubstrate filter of claim 1 wherein the removable second stagebiocompatible substrate filter is a porous and hydrophilic membraneconfigured as an implantable product for implantation within humans. 3.The removable second stage biocompatible substrate filter of claim 2wherein the removable second stage biocompatible substrate filter isconfigured as an implantable product; and wherein the first stageoperative particulate matter and the bone fragments conform to a sizeand geometric shape consistent with an undulated surface of the secondstage filter.
 4. The removable second stage biocompatible substratefilter of claim 1 wherein the second stage is a centrifuge.
 5. Theremovable second stage biocompatible substrate filter of claim 1 whereinthe combined product is configured to unroll into sheets.
 6. Theremovable second stage biocompatible substrate filter of claim 1 whereinthe bone fragments from the first stage are a first size; and whereinthe bone fragments from the second stage operative particulate matter isa second size.
 7. A removable second stage biocompatible substratefilter comprising: biocompatible implant material configured to retainsecond stage operative particulate matter; wherein the removable secondstage biocompatible substrate filter is configured to combine with firststage operative particulate matter captured from irrigation fluid by afirst stage filter; wherein the first stage operative particulate matterincludes material of a first size; and wherein the second stageoperative particulate matter includes material of a second size; andwherein the second stage biocompatible substrate filter is configured tobe removable from a filter device container.
 8. The removable secondstage biocompatible substrate filter of claim 7 wherein the removablesecond stage biocompatible substrate filter is configured to be operablewith a reaming and collection device.
 9. The removable second stagebiocompatible substrate filter of claim 7 wherein the second stageoperative particulate matter retained is one of bone fragments, plasma,stem cells, cellular matter, and growth factors captured from irrigationfluid.
 10. The removable second stage biocompatible substrate filter ofclaim 7 wherein the removable second stage biocompatible substratefilter is configured to receive first stage operative particulate matterthat includes bone fragments.
 11. The removable second stagebiocompatible substrate filter of claim 7 wherein the removable secondstage biocompatible substrate filter is configured to receive firststage operative particulate matter that includes at least one of bonefragments, plasma, stem cells, cellular matter, and growth factorscaptured from irrigation fluid.
 12. A removable second stagebiocompatible substrate filter comprising: biocompatible implantmaterial configured to retain second stage operative particulate matter;wherein the removable second stage biocompatible substrate filter isconfigured to combine with operative particulate matter captured fromirrigation fluid by a first stage filter; wherein the first stageretained material and the second stage retained material are obtainedfrom a reaming device utilizing an irrigation fluid supply and a suctionsource; wherein an output of the reaming device is connected to an inputof a first stage filter container; wherein a flow of materials suspendedin the irrigation fluid passes through a first connecting tube; whereinthe flow of materials suspended in the irrigation fluid is filtered bythe first stage filter; wherein the first stage retained material isseparated from the flow of materials suspended in the irrigation fluidby a filter possessing a first particulate size selectivity thatprovides a first stage output flow of materials suspended in irrigationfluid; wherein the first stage filter allows for collection of a firstsized particulate matter of at least one or more of irrigation fluid,plasma, stem cells, growth factors, and cellular matter; wherein thefirst stage output flow of materials is suspended in the irrigationfluid and passed through a first stage output; wherein an input of asecond stage filter container is connected by a second connecting tubeto the output of the first stage filter container; wherein the firststage output flow of materials suspended in the irrigation fluid isfiltered by the second stage filter; wherein the second stage filterretains a second sized particulate matter different than the first stagefilter; wherein the second stage filter collects a portion of at leastone or more of plasma, stem cells, growth factors, and cellular matter,and allows for passing of a portion of the irrigation fluid, as outputflow; wherein the second stage filter container includes an evacuationport to permit the flow of materials suspended in the irrigation fluidto be evacuated from the second stage filter container in a continuousprocess; wherein the second stage biocompatible substrate filter isconfigured to receive at least a portion of the first stage retainedmaterial in combination with at least a portion of the second stageretained material to create a combined graft product; and wherein thesecond stage biocompatible substrate filter is configured to beremovable from a filter device container.
 13. The removable second stagebiocompatible substrate filter of claim 12 wherein the substrate is aporous and hydrophilic membrane configured as an implantable product forimplantation within humans.
 14. The removable second stage biocompatiblesubstrate filter of claim 12 wherein the removable second stagebiocompatible substrate filter is configured as an implantable product;and wherein the first stage retained material and the second stageretained material conform to a size and geometric shape consistent withan undulated surface of the second stage filter.
 15. The removablesecond stage biocompatible substrate filter of claim 12 wherein thesecond stage is a centrifuge.
 16. The removable second stagebiocompatible substrate filter of claim 12 wherein the combined productis configured to unroll into sheets.
 17. The removable second stagebiocompatible substrate filter of claim 12 wherein the substrate is aporous and hydrophilic membrane of a size and geometric shape consistentwith an undulated surface of the second stage filter configured as animplantable product to envelop a human bone.